Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into glucose, which is the fuel cells need for on-going activity. Published studies indicate that at least 7% of the US population has diabetes, and about 70% of those with diabetes have been diagnosed. About 5-10% of all diabetics have Type I diabetes in which the pancreatic cells that produce insulin have been destroyed. Thus, there are no cells to produce the chemical that produces insulin. Type I diabetes is treated by supplying insulin by injection or pump. The balance of those with diabetes have Type II diabetes in which pancreatic cells produce insulin, but other cells in the body do not use insulin well to convert food into glucose. Type II diabetes is treated by diet, exercise, oral medications, insulin, or a combination thereof.
While diabetes cannot yet be cured, it can be controlled. If it is not controlled, complications result. For example, adults with diabetes have heart disease rates about 2 to 4 times higher than adults without diabetes. The risk for stroke is 2 to 4 times higher among people with diabetes. Diabetes is the leading cause of new cases of blindness among adults aged 20-74 and the leading cause of kidney failure. About 60-70% of people with diabetes have mild to severe forms of nervous system damage. The result of such damage includes impaired sensation or pain in the feet or hands, which may eventually result in amputation of the limb. In addition, people with diabetes are more susceptible to many other illnesses and, once they acquire these illnesses, often have worse prognoses than non-diabetics.
As it stands, if an adult or child would like to know if they are at risk for diabetes, they are required to contact their physician, schedule an appointment, subject themselves to blood tests and then report back to their physician when the results are obtained. This process can be both an expensive and time consuming process for the patient. Due to the cost of both time and money, many individuals forgo proper testing and are therefore not properly diagnosed. Further, this process is made even more difficult for those without primary care physicians or medical insurance to pay for the appointments and testing that is required. Therefore, the remains a need for a self-contained in-vitro diagnostic device that is inexpensive, can be used easily at the home of the patient and provides for a one-time diagnostic check-up.
To control diabetes, it is necessary to monitor the level of glucose in the blood. The frequency of measurement varies from patient to patient, depending on a number of factors including the severity of the disease, type of diabetes, level of physical activity, eating habits, and other health issues. For patients with diabetes, it is often necessary to determine the glucose level in blood several times a day. Consistently taking readings help patients manage their glucose levels better, thereby improving insulin and other therapies and helping to prevent complications.
A common method of blood glucose self-monitoring is to prick a finger or other area to release capillary blood, absorb a minute amount of blood onto a test strip, and insert the test strip into a monitor to measure the amount of glucose in the blood. In particular many devices allow for self assessment of blood glucose for diabetes patients. Many of these devices are small portable diagnostic monitors that use replaceable single-use test strips. By placing a very small volume of blood on such a single use test strip, an electrochemical reaction converts the blood glucose into a small electric current that relatively easily can be converted into a blood glucose value/level within second. These devices further require that the user enter calibration data specific to the test strips being used. Since the prior art devices all require that test strips be entered for each single use, a user is required to enter calibration data each time a new set of test strips is to be used with the device.
Although the current devices typically meet the requirements for disease management of chronic patients, another set of requirements apply in a screening setting, whether for diabetes, high cholesterol, or other physiological conditions. The cost of the device hardware, distribution, training, calibration and data feedback requirements all make the current devices non-practical. Screening therefore typically requires a patient to go to a hospital where a blood sample is taken and the blood sample sent to a laboratory for analysis and testing. Further, it is often desired to have a fasting blood glucose level/value as well as a value after intake of a certain amount of simple sugars, which add timing constraints to the already complicated process. Therefore, there is a need for a device that is economical and self-contained and which allows for a quick screen test in a patient's home environment where the results can be effectively and securely transmitted to a centralized location for diagnosis.